Role of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax

St. Luke's Hospital, Pennsylvania

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hemopneumothorax; Pneumothorax

Treatments: Drug: Placebo; Drug: Ancef or Clindamycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01127880

SLHN 2005-34

Details and patient eligibility

About

The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.

Full description

In this study, the medication (an antibiotic which is used to treat or prevent infections) will be compared with a placebo. A placebo is something that looks like a "real" medication, but it doesn't contain any active medication. As a participant in this study, you may receive the active medication (Cefazolin Sodium Injection or Clindamycin) or you may receive a placebo.

Enrollment: 50 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥ 16 years of age.
2. Admission to Trauma, General Surgery, and/or Surgical Critical Care services.
3. Traumatic pneumothorax, hemothorax or hemopneumothorax

Exclusion criteria

1. Pregnancy
2. Open fracture
3. Immunocompromised
4. Require antibiotics for treatment of other injuries
5. Chest tube placement greater than 72hrs after admission

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Ancef 1 gm or Clindamycin 300 mg

Active Comparator group

Description:

Group A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists

Treatment:

Drug: Ancef or Clindamycin

Placebo

Placebo Comparator group

Description:

Group B will receive .9% Normal Saline as a placebo.

Treatment:

Drug: Placebo